Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-13 @ 4:43 AM
Study NCT ID:
NCT00449033
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2007-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'Bayer HealthCare AG'}, 'certainAgreement': {'otherDetails': 'The investigator, whilst free to use data from the study for scientific purposes, must not publish any document relating to the Trial without first notifying Bayer in writing and obtaining written consent. Bayer recognizes the right of the investigator to publish the results upon completion of the study. The investigator must send a draft manuscript of the publication or abstract to Bayer 60 days ahead of submission to obtain approval prior to submission of the final version for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Inclusion of squamous patients stopped in FEB 2008, as 11961 (NCT00558636) trial reported higher mortality for this subgroup. Squamous patients in 12006 (NCT00449033) trial discontinued drug as a precaution endorsed by Data Monitoring Committee.'}}, 'adverseEventsModule': {'description': 'Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)', 'eventGroups': [{'id': 'EG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.', 'otherNumAtRisk': 452, 'otherNumAffected': 440, 'seriousNumAtRisk': 452, 'seriousNumAffected': 270}, {'id': 'EG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.', 'otherNumAtRisk': 449, 'otherNumAffected': 435, 'seriousNumAtRisk': 449, 'seriousNumAffected': 198}], 'otherEvents': [{'term': 'Blood - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Edema: Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 221}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 146}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 225}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 255}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 210}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 34}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 158}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 133}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 80}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Mucositis (functional/symptomatic), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 263}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 247}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Taste Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 198}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 242}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 237}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Chest/Thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Extremity - limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Head/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Throat/Pharynx/Larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 55}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Metabolic/Lab - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 77}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 106}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dyspnea (Shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 86}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Voice changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 74}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dermatology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 93}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage pulmonary, Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 33}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}], 'seriousEvents': [{'term': 'Blood - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Bone marrow cellularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Edema: Head and Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Edema: Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cardiac arrhythmia - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cardiac general - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cardiac ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Conduction abnormality, Conduction abnormality NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Supraventricular arrhythmia, Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Supraventricular arrhythmia, Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Supraventricular arrhythmia, Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Ventricular arrhythmia, Ventricular arrhythmia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Ventricular arrhythmia, Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Endocrine - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Optic disc edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'GI - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Ileus', 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'EG001', 'numAtRisk': 449, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Obstruction, GI, Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Obstruction, GI, Gallbladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Obstruction, GI, Ileum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Perforation, GI, Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Perforation, GI, Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Stricture, GI, Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Stricture, GI, Esophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Constitutional symptoms - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Death not associated with CTCAE term, Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Death not associated with CTCAE term, Disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Death not associated with CTCAE term, Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Death not associated with CTCAE term, Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'No code in CTCAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Chest/Thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Extremity - limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Gallbladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Head/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Neuralgia/Peripheral nerve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pain, Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hepatobiliary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Liver dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Bladder (urinary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Lung (Pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Pleura (Empyema)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection (Documented clinically), Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Anal/perianal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Lung (Pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Meninges (Meningitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Scrotum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Skin (cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Soft tissue NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with normal ANC, Urinary tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with unknown ANC, Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with unknown ANC, Lung (Pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with unknown ANC, Pleura (Empyema)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with unknown ANC, Soft tissue NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Infection with unknown ANC, Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Intraop injury, Jejunum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Intraop injury, Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Bilirubin (Hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'GFR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Muscle weakness, Extremity - lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Muscle weakness, Whole body/generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Musculoskeletal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Soft tissue necrosis, Extremity - lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'CNS ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Mood alteration, Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neuropathy: Cranial, CN II Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Personality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pyramidal tract dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Speech impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Syncope (Fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Renal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'ARDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Airway obstruction, Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dyspnea (Shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Pulmonary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Dermatology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Artery injury, Aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'CNS hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage pulmonary, Bronchopulmonary NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage pulmonary, Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage pulmonary, Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage pulmonary, Respiratory tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Anus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Hemorrhage, GI, Upper GI NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Peripheral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Thrombosis/Embolism (vascular access)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Thrombosis/Thrombus/Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Vascular - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}, {'term': 'Visceral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE v.3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000', 'lowerLimit': '333', 'upperLimit': '416'}, {'value': '379', 'groupId': 'OG001', 'lowerLimit': '335', 'upperLimit': '414'}]}]}], 'analyses': [{'pValue': '0.401', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.16', 'groupDescription': 'Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.'}, {'type': 'SECONDARY', 'title': 'OS in the ITT (Both Squamous and Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000', 'lowerLimit': '322', 'upperLimit': '410'}, {'value': '378', 'groupId': 'OG001', 'lowerLimit': '335', 'upperLimit': '412'}]}]}], 'analyses': [{'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.'}, {'type': 'SECONDARY', 'title': 'OS in the ITT (Squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000', 'lowerLimit': '197', 'upperLimit': '455'}, {'value': '374', 'groupId': 'OG001', 'lowerLimit': '282', 'upperLimit': '519'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '208'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '156', 'upperLimit': '174'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000', 'lowerLimit': '171', 'upperLimit': '210'}, {'value': '167', 'groupId': 'OG001', 'lowerLimit': '156', 'upperLimit': '173'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.88', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}, {'title': 'confirmed PR', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '32.6'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '30.5'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '39.3'}, {'value': '37.2', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '42.2'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '14.5'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '21.2'}]}]}, {'title': 'Not assessable', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '31.7'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '24.2'}]}]}], 'analyses': [{'pValue': '0.2733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Tumour Response (CR+PR)', 'ciPctValue': '95', 'paramValue': '-1.92', 'ciLowerLimit': '-8.19', 'ciUpperLimit': '4.34', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of Tumour Response based on ITT (non-squamous) population.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000'}, {'value': '63.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Disease Control', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '-5.87', 'ciUpperLimit': '7.81', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of Disease Control based on ITT (non-squamous) population.'}, {'type': 'SECONDARY', 'title': 'Duration of Response in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '147', 'upperLimit': '203'}, {'value': '133', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '146'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease (SD) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '168'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '125', 'upperLimit': '156'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '44'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'title': 'cycle 2 (day 22)', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '92.6'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '95.9'}]}]}, {'title': 'cycle 4 (day 64)', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '92.2'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '95.4'}]}]}, {'title': 'cycle 6 (day 106)', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '91.8'}, {'value': '93.1', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '95.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from randomization of the first patient until 38 months', 'description': 'The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients valid for the ITT analysis who have a baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'title': 'cycle 1 (day 1)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '20.4'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '20.9'}]}]}, {'title': 'cycle 2 (day 22)', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '20.4'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '20.8'}]}]}, {'title': 'cycle 3 (day 43)', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '20.3'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.8'}]}]}, {'title': 'cycle 4 (day 64)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '20.2'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '20.7'}]}]}, {'title': 'cycle 5 (day 85)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '20.2'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '20.7'}]}]}, {'title': 'cycle 6 (day 106)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '20.1'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '20.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from randomization of the first patient to 38 months later or death whatever occurs first.', 'description': 'LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients valid for the ITT analysis who have a baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '8.7'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization of the first patient to 38 months later or death whatever occurs first', 'description': 'TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients valid for the ITT analysis who have a baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'title': 'cycle 1 (day 1)', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.72'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.78'}]}]}, {'title': 'cycle 2 (day 22)', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.72'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.78'}]}]}, {'title': 'cycle 3 (day 43)', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.71'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '0.77'}]}]}, {'title': 'cycle 4 (day 64)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.71'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '0.76'}]}]}, {'title': 'cycle 5 (day 85)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.70'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.76'}]}]}, {'title': 'cycle 6 (day 106)', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.70'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '0.75'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from randomization of the first patient until 38 months later or death whatever occurs first', 'description': 'The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients valid for the ITT analysis who have a baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'OG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'classes': [{'title': 'cycle 1 (day 1)', 'categories': [{'measurements': [{'value': '66.43', 'groupId': 'OG000', 'lowerLimit': '64.65', 'upperLimit': '68.21'}, {'value': '68.96', 'groupId': 'OG001', 'lowerLimit': '67.18', 'upperLimit': '70.73'}]}]}, {'title': 'cycle 2 (day 22)', 'categories': [{'measurements': [{'value': '66.43', 'groupId': 'OG000', 'lowerLimit': '64.68', 'upperLimit': '68.18'}, {'value': '68.96', 'groupId': 'OG001', 'lowerLimit': '67.19', 'upperLimit': '70.72'}]}]}, {'title': 'cycle 3 (day 43)', 'categories': [{'measurements': [{'value': '66.43', 'groupId': 'OG000', 'lowerLimit': '64.68', 'upperLimit': '68.18'}, {'value': '68.95', 'groupId': 'OG001', 'lowerLimit': '67.18', 'upperLimit': '70.72'}]}]}, {'title': 'cycle 4 (day 64)', 'categories': [{'measurements': [{'value': '66.43', 'groupId': 'OG000', 'lowerLimit': '64.65', 'upperLimit': '68.20'}, {'value': '68.95', 'groupId': 'OG001', 'lowerLimit': '67.15', 'upperLimit': '70.75'}]}]}, {'title': 'cycle 5 (day 85)', 'categories': [{'measurements': [{'value': '66.42', 'groupId': 'OG000', 'lowerLimit': '64.61', 'upperLimit': '68.24'}, {'value': '68.95', 'groupId': 'OG001', 'lowerLimit': '67.10', 'upperLimit': '70.80'}]}]}, {'title': 'cycle 6 (day 106)', 'categories': [{'measurements': [{'value': '66.42', 'groupId': 'OG000', 'lowerLimit': '64.55', 'upperLimit': '68.30'}, {'value': '68.95', 'groupId': 'OG001', 'lowerLimit': '67.02', 'upperLimit': '70.87'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from randomization of the first patient until 38 months later or death whatever occurs first', 'description': "The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients valid for the ITT analysis who have a baseline and at least one post baseline value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'FG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'comment': 'Reasons for not treated: Adverse event (N=1); Consent withdrawn (N=1); Reason missing (N=1)', 'groupId': 'FG001', 'numSubjects': '452'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'groupId': 'FG001', 'numSubjects': '449'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'groupId': 'FG001', 'numSubjects': '452'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Amended Protocol Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Second Malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Treatment Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '425 entered, comprising 452 randomized less 21 deaths \\& 6 ongoing on treatment', 'groupId': 'FG000', 'numSubjects': '425'}, {'comment': '434 entered, comprising 452 randomized less 12 deaths, 2 lost to follow-up \\& 4 ongoing on treatment', 'groupId': 'FG001', 'numSubjects': '434'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '425'}, {'groupId': 'FG001', 'numSubjects': '434'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '311'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Reason Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '113'}]}]}], 'recruitmentDetails': 'This study was conducted at 93 centers across 16 countries, which enrolled and randomized at least one patient. From a total of 1011 patients who were screened, 904 patients were randomized between 23 FEB 2007 and 03 MAR 2009.', 'preAssignmentDetails': 'All 904 randomized patients were included in the intent to treat (ITT) population. A total of 901 patients received at least one dose of study medication and were included in the safety population. Study medication included administration of any one of the following treatments: gemcitabine, cisplatin, sorafenib or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'BG000'}, {'value': '452', 'groupId': 'BG001'}, {'value': '904', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.'}, {'id': 'BG001', 'title': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '81'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '82'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '581', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'histology of the tumor', 'classes': [{'title': 'Non-squamous', 'categories': [{'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '772', 'groupId': 'BG002'}]}]}, {'title': 'Squamous', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Time since initial diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '552'}, {'value': '2.9', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '924'}, {'value': '2.7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '924'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'Smoking history', 'classes': [{'title': 'Non-smoker', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}, {'title': 'Passive smoker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Past or present smoker', 'categories': [{'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}]}, {'title': 'Not available', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor stage at randomization', 'classes': [{'title': 'Stage III B', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '792', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Categorized information on tumor size, lymph node involvement and metastases. Stages I-IV. The higher the stage the more advanced cancer. Stage IIIB versus IV was a stratification factor for randomization. Stage IIIB (according to American Joint Committee on Cancer): primary tumor any stage, regional lymph node stage N3, no distant metastasis OR primary tumor stage T4, regional lymph node any stage, no distant metastasis. Stage IV: primary tumor any stage, regional lymph node any stage, distant metastasis present.', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG (Eastern Cooperative Oncology Group) Performance Status at randomization', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG 0 versus 1 was a stratification factor for randomization. ECOG Performance Status is a rating of daily living abilities, from 0 to 5: 0= fully active without restriction. 1= restricted in physically strenuous activity; 2= ambulatory, capable of all selfcare; 3= capable of limited selfcare; 4= completely disabled; 5= dead.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 904}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2007-03-16', 'resultsFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2007-03-16', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-08', 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.'}], 'secondaryOutcomes': [{'measure': 'OS in the ITT (Both Squamous and Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.'}, {'measure': 'OS in the ITT (Squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.'}, {'measure': 'Progression-free Survival (PFS) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.'}, {'measure': 'Time to Progression (TTP) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.'}, {'measure': 'Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.'}, {'measure': 'Disease Control (DC) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.'}, {'measure': 'Duration of Response in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.'}, {'measure': 'Duration of Stable Disease (SD) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks', 'description': 'Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.'}, {'measure': 'Time to Response (TTR) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months or date of death of any cause whichever came first', 'description': 'TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.'}, {'measure': 'Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months', 'description': 'The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.'}, {'measure': 'Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient to 38 months later or death whatever occurs first.', 'description': 'LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.'}, {'measure': 'Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient to 38 months later or death whatever occurs first', 'description': 'TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.'}, {'measure': 'Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months later or death whatever occurs first', 'description': 'The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.'}, {'measure': 'EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population', 'timeFrame': 'from randomization of the first patient until 38 months later or death whatever occurs first', 'description': "The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer (NSCLC)', 'Cancer'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '22851564', 'type': 'RESULT', 'citation': 'Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, Zhang L, Liao M, Sun Y, Gans S, Syrigos K, Le Marie E, Gottfried M, Vansteenkiste J, Alberola V, Strauss UP, Montegriffo E, Ong TJ, Santoro A; NSCLC [non-small-cell lung cancer] Research Experience Utilizing Sorafenib (NExUS) Investigators Study Group. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol. 2012 Sep 1;30(25):3084-92. doi: 10.1200/JCO.2011.39.7646. Epub 2012 Jul 30.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for Bayer Product information provided by EMA'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)', 'detailedDescription': "During follow-up, it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients' data are reported in the current CSR addendum, 6 in the sorafenib + GC group and 4 in the placebo + GC group, and as before all in the ITT (non-squamous) population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years old\n* Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC of non-squamous cell carcinoma subtype. (thoracentesis or pericardiocentesis is not necessary if a biopsy of the original tumor is available to confirm diagnosis of NSCLC).\n* Patients with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix 10.3)\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:\n* Hemoglobin \\>/= 9.0 g/dl (\\>/= 5.6 mmol/l)\n* Absolute neutrophil count (ANC) \\>/= 1,500/mm3\n* Platelet count \\>/= 100,000/µl\n* Total bilirubin \\</= 1.5 x upper limit of normal\n* Alanine transaminase (ALT) and Aspartate transaminase (AST) \\</= 2.5 x upper limit of normal (\\</= 5 x upper limit of normal for patients with liver involvement of their cancer)\n* Alkaline Phosphatase \\</= 4 x upper limit of normal\n* PT-INR (Prothrombin Time - International Normalized Ratio) (international normalized ratio of PT) /PTT (Partial Thromboplastin Time) \\< 1.5 x upper limit of normal\n* Serum Creatinine \\</= 1.5 times the upper limit of normal and Serum Creatinine Clearance \\>/= 70ml/min\n* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Excluded medical conditions:\n\n * Cardiac disease: Congestive heart failure \\> class II NYHA (New York Heart Association). Patients must not have unstable angina (anginal symptoms at rest) or active coronary artery disease (CAD), or myocardial infarction within the past 6 months\n * Cardiac arrhythmias requiring anti-arrhythmic therapy\n * Uncontrolled hypertension defined as systolic blood pressure \\> 150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management.\n * History of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C\n * Active clinically serious infections (\\> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0)\n * Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)\n * Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.\n * History of organ allograft\n * Patients with evidence or history of bleeding diathesis or coagulopathy\n * Patients undergoing renal dialysis\n * Cancer other than NSCLC within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors \\[Ta (Noninvasive tumor), Tis (Carcinoma in situ) \\& T1 (Tumor invades lamina propria)\\]\n * Uncontrolled hypertension defined as systolic blood pressure \\> 150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management.\n * Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months\n * Pulmonary hemorrhage/bleeding event \\> Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug\n * Any other hemorrhage/bleeding event \\> CTCAE Grade 3 within 4 weeks of first dose of study drug\n * Serious, non-healing wound, ulcer, or bone fracture\n * Uncorrected dehydration\n * Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.\n * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n * Known or suspected allergy to the investigational agent or any agent given in association with this trial\n * Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study\n * Patients unable to swallow oral medications\n * Any malabsorption condition\n * Patients with a hearing impairment (FOR GERMANY ONLY)\n * NSCLC patients with squamous cell carcinoma diagnosis documented either by cytology or biopsy.\n* Excluded therapies and medications, previous and concomitant:\n\n * Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC\n * Concomitant use of nephrotoxic drugs, ototoxic drugs, anticonvulsant, anti-gout treatment\n * Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section)\n * Radiotherapy during study or within 4 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section) (FOR FRANCE ONLY)\n * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug (bronchoscopy is allowed)\n * Granulocyte colony stimulating factor (GCSF) or Granulocyte macrophage colony stimulating factor (GMCSF), within 3 weeks of study entry (these growth factors may be used during the study thereafter)."}, 'identificationModule': {'nctId': 'NCT00449033', 'acronym': 'NEXUS', 'briefTitle': 'A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '12006'}, 'secondaryIdInfos': [{'id': '2006-002688-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib (Nexavar, BAY43-9006) + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.', 'interventionNames': ['Drug: Sorafenib (Nexavar, BAY43-9006)', 'Drug: Gemcitabine', 'Drug: Cisplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + GC', 'description': 'Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\\^2 infusion (IV), followed by cisplatin 75 mg/ m\\^2 IV; Day 8: gemcitabine 1250 mg/ m\\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.', 'interventionNames': ['Drug: Placebo', 'Drug: Gemcitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Sorafenib (Nexavar, BAY43-9006)', 'type': 'DRUG', 'description': 'Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\\^2 IV, Cisplatin 75 mg/m\\^2 IV', 'armGroupLabels': ['Sorafenib (Nexavar, BAY43-9006) + GC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\\^2 IV, Cisplatin 75 mg/m\\^2 IV', 'armGroupLabels': ['Placebo + GC']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Chemotherapy component; Gemcitabine 1250 mg/m\\^2 IV', 'armGroupLabels': ['Placebo + GC', 'Sorafenib (Nexavar, BAY43-9006) + GC']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Chemotherapy component; Cisplatin 75 mg/m\\^2 IV', 'armGroupLabels': ['Placebo + GC', 'Sorafenib (Nexavar, BAY43-9006) + GC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4010', 'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2930', 'city': 'Brasschaat', 'country': 'Belgium', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '1200', 'city': 'Bruxelles - Brussel', 'country': 'Belgium'}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 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